Balversa Erdafitinib Tablets

Product Description

1. Technical Specifications

---

2. Product Description

Balversa (Erdafitinib) is an oral selective fibroblast growth factor receptor (FGFR) inhibitor.

It works by inhibiting FGFR2 and FGFR3 kinases, which are often altered in urothelial carcinoma and drive tumor cell proliferation. By blocking FGFR signaling, it suppresses cancer cell growth and induces tumor regression.

---

3. Product Highlights

---

4. Therapeutic Uses

• Locally advanced or metastatic urothelial carcinoma in adults with FGFR3 or FGFR2 genetic alterations,

  • who have progressed during or following platinum-containing chemotherapy,

  • including within 12 months of neoadjuvant or adjuvant platinum-based chemotherapy.

---

5. Side Effects

Common:

• Hyperphosphatemia ( phosphate levels in blood)

• Stomatitis (mouth sores)

• Diarrhea, constipation

• Fatigue

• Dry mouth

• Decreased appetite, weight loss

• Eye disorders (dry eye, blurred vision)

• Hair loss (alopecia)

• Nausea, vomiting

Serious / Severe:

• Ocular toxicity (central serous retinopathy, retinal pigment epithelial detachment vision loss if untreated)

• Severe hyperphosphatemia risk of soft tissue mineralization

• Electrolyte imbalance

• Severe skin reactions (hand-foot syndrome)

• Risk of fetal harm if taken during pregnancy

---

6. Precautions

• Genetic Testing: FGFR genetic alterations must be confirmed before initiating therapy.

• Phosphate Monitoring: Regular serum phosphate checks (dose adjustments may be needed).

• Ophthalmologic Exams: Baseline and monthly eye exams during first 4 months, then as clinically indicated.

• Pregnancy & Breastfeeding: Contraindicated due to fetal toxicity risk.

• Drug Interactions: Avoid strong CYP2C9 and CYP3A4 inducers/inhibitors.

• Hydration & Diet: May need phosphate-lowering interventions (diet or medication).

Powerful Oral Therapy for Bladder Cancer

Balversa utilizes Erdafitinib as its active ingredient to target and treat advanced urothelial carcinoma, specifically in patients with FGFR genetic alterations. Its film-coated tablet form allows for convenient oral administration, making it suitable for home use with proper physician guidance.


Targeted Treatment Approach

Designed for those battling locally advanced or metastatic bladder cancer, Balversa delivers precise therapy by focusing on specific genetic mutations. This enhances treatment effectiveness and can offer improved patient outcomes compared to non-targeted chemotherapy.


Safe Storage and Handling

Balversa should be stored below 30C in a cool, dry place, away from children. Appropriate storage ensures the medicines stability over its 1-year shelf life. Always use under medical supervision to maximize safety and therapeutic benefit.